Pharmaceutical Project Manager - External Manufacturing

Cynet Systems•Indianapolis, IN

About The Position

The organization is seeking a Project Manager to provide strategic and operational project leadership across API external manufacturing, supporting the management of commercial supply and related initiatives at a contract manufacturing organization (CMO). This role integrates activities across quality, supply chain, engineering, regulatory, and finance, translating program strategy into disciplined execution to ensure reliable commercial supply of key therapeutics.

Requirements

Bachelor's degree in engineering, a scientific field, or a related technical discipline.
A minimum of 5 years of relevant experience in pharmaceutical/biopharmaceutical operations.
Experience overseeing project lifecycle of commercial or external manufacturing at a contract manufacturer (CMO/CDMO), including quality oversight, supply coordination, deviation/CAPA and change-control interfaces, and contract governance.
Demonstrated experience applying project management tools and processes — scheduling, risk management, phase-gate/stage-gate governance — across cross-functional teams spanning quality, supply chain, engineering, regulatory, and finance in a GMP environment.
Proficiency with Microsoft Word, Excel, PowerPoint, and project scheduling tools (e.g., MS Project, Primavera P6, Smartsheet).
Capable of maintaining appropriate project documentation.

Nice To Haves

Advanced degree or professional certification (e.g., MS, MBA, Master's in Project Management, PMP, or a commissioning/qualification/validation credential) preferred.

Responsibilities

Facilitate and support contract manufacturing organization (CMO) oversight and project delivery.
Manage scope and support creation of an integrated project plan that articulates the strategy for the CMO relationship and its key initiatives, and provides the foundation for operational objectives and milestones.
Coordinate cross-functional obligations between the organization and the CMO, including quality oversight, supply coordination, deviation/CAPA and change-control interfaces, and contract and governance commitments.
Create and execute project plans and drive delivery of project milestones across the initiative lifecycle.
Develop and implement team communication plans and drive communication of key decisions, risks, and results to stakeholders and leadership.
Monitor and prioritize project and supply risks, suggest ways to avoid or mitigate risks, and initiate contingency plans as needed.
Bring forward areas for continual process improvement to strengthen schedule discipline, reduce cost, and improve reliability of commercial supply and project delivery.
Drive development of an integrated project budget and support financial governance, ensuring alignment with functional representatives, finance, and leadership.
Maintain proficiency in self-management and organizational skills; the candidate must be able to manage workload, set personal and team priorities, and adjust as needed in a dynamic, multi-workstream environment.
Demonstrate strong interpersonal and team-building skills; the candidate must be able to develop effective teamwork between the organization and CMO team members with diverse styles and across organizational boundaries.